Grant: Project Grant

Coronary artery bypass surgery (CABG) is an operation to improve the circulation of the heart where healthy blood vessels from the patient are used to go around blockages of the heart arteries, like a detour. The standard operation consists of a chest wall artery for one of the bypasses and leg veins for the others, although leg veins can develop blockages over time compared to arteries. While using at least one artery compared to only veins is known to improve outcomes, whether the use of more arteries improves outcomes following CABG is uncertain. The CIHR-funded ROMA study is a randomized clinical trial testing whether the use of two or more bypass grafts using arteries from the chest wall or arm improves cardiovascular outcomes compared to one artery and veins late after CABG. This international, multicentre study of 4,300 patients with extended follow-up after CABG (completion of enrollment March 2023), will determine whether the use of two or more arterial grafts improves important outcomes. Women represent a minority of patients in CABG trials, including ROMA (based on current enrollment, expected 690 women altogether). There are important biological differences and surgical considerations between men and women undergoing CABG, so that ROMA will not provide a meaningful assessment of the effect of multiple artery grafts in women. The proposed ROMA:Women trial is a continuation of enrollment of women exclusively after completion of enrollment of ROMA, for a total sample size of 2,000 women (ROMA and ROMA:Women combined). There is a unique opportunity to leverage the existing trial infrastructure and the enrolled population of women to realize the first cardiac surgery trial dedicated to women. The study will confidently determine the impact of multiple arterial grafts on important cardiovascular outcomes and quality of life in women. This application is for funding for recruitment of the Canadian participants in the international ROMA:Women network.